Qu Biologics Completes Enrollment in First Stage of Phase 2 Clinical Trial in Moderate to Severe Crohn’s Disease
VANCOUVER, British Columbia, Dec. 18, 2019 (GLOBE NEWSWIRE) -- Qu Biologics Inc., a biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel immunotherapy platform designed to restore innate immune function, is pleased to announce the completion of enrollment for the first stage of the RESTORE clinical trial, “A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects with Moderate to Severe Crohn’s Disease”.
In this open-label first stage of a 170-patient study, 20 patients with moderate to severe Crohn’s disease will be treated for up to 52 weeks with the novel investigational agent, QBECO SSI, which is designed to restore, rather than suppress, immune function. Throughout the study treatment period, clinical symptom and endoscopic outcome data are being evaluated to determine the appropriate remission induction treatment period for the study’s next stage. The study also includes important exploratory endpoints correlated with QBECO SSI response, including immune biomarkers, histology and microbiome assessment.
This trial is a follow-on study to Qu’s first study in CD, which was a 68-patient randomized placebo-controlled trial designed to assess improvement of clinical symptoms with QBECO treatment over a 16-week period. This 68 patient study demonstrated a substantial decrease in Crohn’s disease activity index (CDAI) score after 8 weeks of treatment with continued improvement over the 16-week course of study treatment. Qu’s QBECO SSI achieved statistically significant improved response compared to placebo in anti-TNF? naïve patients in this small study, demonstrating proof-of-concept of this novel immunomodulatory approach. The results of Qu’s previous CD trial were published earlier this year in Frontiers in Medicine.
“Completion of enrolment in this first stage of our RESTORE Phase 2 study is an important milestone and we would like to thank the patients for their participation in this clinical trial,” stated Qu Biologics CEO Hal Gunn. “Through their contribution together with the Investigators and study staff, this trial will help us better understand the contribution that QBECO SSI may have on the treatment of this challenging disease and on improving lives of those with Crohn’s disease.”
The 150 patient second stage of the RESTORE Phase 2 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of QBECO SSI for the treatment of moderate to severe CD subjects in Canada, the US and Europe. The endpoints of this study include the induction of clinical and endoscopic remission at week 16 and 26 and maintenance of remission assessed at week 52.
For more information about Qu Biologics and the science behind SSIs, please visit www.qubiologics.com.
About Qu Biologics
Qu Biologics is a clinical stage biotechnology company developing Site Specific Immunomodulators (SSI), a novel class of immunotherapies designed to stimulate an innate immune response in targeted organs to reverse the chronic inflammation underlying many important diseases including inflammatory bowel disease, cancer, inflammatory lung disease and arthritis. Qu has completed three Phase 2 studies in Crohn’s disease, ulcerative colitis and lung cancer.
Backed by a prestigious group of scientific advisors and board members, Qu Biologics is led by a management team that includes co-founder and CEO Dr. Hal Gunn, a physician and expert on the body’s immune response to chronic disease; and Chief Medical Officer Dr. Simon Sutcliffe, former CEO of the BC Cancer Agency and a distinguished clinician, scientist and leader in cancer control in Canada and internationally.
For more information regarding this press release, contact:
Hal Gunn, MD
Qu Biologics Inc.
Qu Biologics Inc. cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Qu Biologics’ forward-looking statements due to the risks and uncertainties inherent in Qu Biologics’ business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Qu Biologics does not assume any obligation to update any forward-looking statements except as required by law.
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